# Translating Lp(a) biology to clinical applications

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2024 · $615,146

## Abstract

This proposal intends to generate novel, widely available reagents and methods to Improve the
measurement of Lp(a) levels in order to improve patient care. Elevated Lp(a) levels are highly prevalent and
generally accepted as an independent, genetic and likely causal risk factor for CVD. Although Lp(a) levels
are measured in clinical laboratories, it is one of the most difficult laboratory analytes to measure accurately
because of its unique structure of multiple, identical kringle repeats. Significant technological and
methodological gaps exist that limit the accuracy of Lp(a) measurements at the both the clinical laboratory
and clinical level. The major limitation is the lack of widely available, globally standardized, diagnostic
methods, and specifically monoclonal antibodies that bind only once to Lp(a) that can be used to accurately
quantitate Lp(a). This lack of standardization may have adverse clinical sequalae by mis-assigning Lp(a) risk
thresholds or targets for therapy. Due to the limitations noted above, the FDA has yet to approve any Lp(a)
assay in molar concentration. The NHLBI Working Group on Lp(a) organized 2 workshops in 2017 and 2019
and recommended constructive collaboration among all stakeholders to ensure standardization and
harmonization of Lp(a) assays and to develop assays that are isoform independent using monoclonal
antibodies that are specific to one site on apo(a). To address these gaps in the care of patients with elevated
Lp(a), we propose the following specific aims: 1- to develop and validate an isoform independent Lp(a) assay
with a recently generated isoform-independent, monoclonal antibody; 2- to generate a second, isoform-
independent, monoclonal antibody to facilitate the development of a first, isoform-independent non-ELISA
methodology adaptable to hospitals and commercial laboratories. We will collaborate with the CDC/IFCC to
validate this new ELISA at the clinical laboratory interface; and 3- to apply these novel assays to clinical
datasets for translatability to human disease, including studies of racial/ethnic differences, antisense Lp(a)-
lowering therapy and in CVD outcome studies.

## Key facts

- **NIH application ID:** 10814875
- **Project number:** 5R01HL159156-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** SOTIRIOS TSIMIKAS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $615,146
- **Award type:** 5
- **Project period:** 2022-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10814875

## Citation

> US National Institutes of Health, RePORTER application 10814875, Translating Lp(a) biology to clinical applications (5R01HL159156-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10814875. Licensed CC0.

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